BAA-NIH-NHLBI-HC-99-06

"Early Access to Defibrillation for Victims of Out-of-Hospital Cardiac Arrest (OOH CA)"

Broad Agency Announcement No.: NIH-NHLBI-HC-99-06
Issue Date: December 7, 1998
Issued By: Lisa T. O'Neill, Contracting Officer
National Heart, Lung, and Blood Institute
Contracts Operations Branch, DEA
Rockledge 2, Room 6122
6701 ROCKLEDGE DR MSC 7902
BETHESDA MD 20892-7902

Purchase Authority: Public Law 95-83, as amended
Small Business Set-Aside: No; SIC Code 8731
Proposal Due Date: March 1, 1999, 4:00 P.M. (Eastern Time)


Ladies and Gentlemen:

The National Heart, Lung, and Blood Institute is issuing a Broad Agency Announcement for studies testing intervention strategies for promoting early access to defibrillation for victims of out-of-hospital cardiac arrest (OOH-CA). This announcement is intended to encourage creative intervention approaches to achieving early access to defibrillation for OOH CA; accordingly, the announcement avoids specifying any particular approach. Proposals should use intervention strategies that aim to enhance early access to defibrillation for OOH CA and should include survival, morbidity, and functional outcome measures (such as activities of daily living). It is critical that any strategy employed be generalizable to a large segment of the OOH CA population, i.e., have major implications for public health. Only randomized clinical trials will be considered responsive to the announcement. If technology or devices are to be incorporated into the intervention strategy, the technology or device should already have been proven to be efficacious and safe, and the intervention to be tested should focus on the approach or strategy for implementing the technology/device. This Broad Agency Announcement consists of this combined solicitation form and cover letter (PART A), and four attachments, as follows:

Attachments:

  1. Background;
  2. Evaluation Factors for Award, including Technical Evaluation Criteria and Other Information;
  3. Specific BAA Instructions and Provisions;
  4. Applicable RFP References

Attachments A and B contain the technical information required for the submission of a proposal for this acquisition. Attachment C, titled "Specific BAA Instructions and Provisions" contains, for example, the proposal intent response form and the address for delivery of your proposal. Section D, titled "Applicable RFP References" lists those items in the "Streamlined RFP References" directory that apply to this Broad Agency Announcement, including forms that can be downloaded and are required for the submission of a proposal. Your attention is further directed to the "Proposal Intent Response Sheet" contained in Attachment C. Please complete this form and return it to this office on or before January 29,1999. This will allow us to expedite preparations for the peer review of proposals.

The Business and Technical proposals must be separate from one another in the proposal package. The Business proposal must be signed by an authorized official of your organization and must contain a detailed breakdown of costs by year for each cost category. The basis for costs must be explained and supporting documentation must be submitted with the proposal. (See "STANDARD RFP INSTRUCTIONS and PROVISIONS" in the RFP homepage for more detail on the Business proposal requirements. Your proposal (Business and Technical) must be received no later than March 1, 1999, at 4:00 p.m.(Eastern Time) at the address and quantity specified in Attachment C., titled "Packaging and Delivery of Proposals". (NOTE: IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR DESIGNEE AT THE PLACE AND TIME SPECIFIED, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH THE PHS CLAUSE 352.215-10 TITLED, "LATE PROPOSALS, MODIFICATIONS OF PROPOSALS, AND WITHDRAWALS OF PROPOSALS".)

Offers will be valid for 120 days unless a different period is specified by the offeror on the form titled, "Proposal Summary and Data Record, NIH 2043" also located at the site for FORMS, FORMATS, AND ATTACHMENTS.

Sincerely,


Lisa T. O'Neill
Contracting Officer

ATTACHMENTS


ATTACHMENT A

BACKGROUND AND WORK STATEMENT

  1. PROJECT DESCRIPTION

    The proposed contract program is for a broad agency announcement (BAA) to solicit proposals for intervention studies designed to test strategies for promoting early access to defibrillation for victims of out-of-hospital cardiac arrest (OOH CA).

  2. BACKGROUND AND HISTORY

    Despite a decline in mortality from coronary heart disease (CHD) in the U.S., including a marked decline in case fatality from hospitalized myocardial infarction (MI), little improvement has been made in survival from sudden, unexpected out of hospital cardiac arrest (OOH CA). Approximately 60% of the 489,171 deaths attributable to CHD in 1990 were thought to be due to CA resulting in sudden cardiac death (SCD). Assuming a conservative estimate of the incidence of OOH CA in this country at 200,000 per year, and assuming a conservative estimate of 60% of these events being witnessed, an increase in the survival rate from 5% to 15% would save 12,000 American lives annually.

    A ventricular tachyarrhythmia is responsible for the majority of cardiac arrests in adults who experience sudden, unexpected OOH CA. Electrical defibrillation is very effective at terminating these arrhythmias, but its effectiveness is highly time dependent. If defibrillation can be accomplished in the first minute of the cardiac arrest, survival is as high as 90%. With each passing minute, the likelihood of survival without neurological deficit decreases by about 10%. By 10 minutes after the arrest, defibrillation results in long-term survival without neurological deficit in less than 10% of victims, i.e., more than 90% of victims do not survive or do not survive neurologically intact.

    The survival rate from OOH CA varies widely across the U.S. For example, 32% of patients with witnessed cardiac arrest in Seattle, Washington, survived to leave the hospital when bystanders performed cardiopulmonary resuscitation (CPR) and 22% survived without bystander CPR. In rural areas where emergency vehicles are nonexistent or remote and travel time is long, survival rates are extremely low. Similarly, in many urban areas there are very few survivors of out-of-hospital cardiac arrest. For example, Becker and colleagues reported an overall 2% survival rate with 55 of 3,221 resuscitation victims leaving the hospital in Chicago in 1987. The picture was similar in 1991 in New York City, where only 26 out of 2,329 victims of apparent cardiac arrest survived to leave the hospital (1.4%). In New York City, as in Seattle, bystander CPR improved outcome, but only modestly. Survival was 2.9% in the one-third of victims who received bystander CPR compared with 0.8% in those who received no bystander CPR. These rates are consistent with those reported by active field investigators. Cities that have low rates of survival have unacceptably long delays from the onset of cardiac arrest to defibrillation. In New York City the median time to first shock was 12.4 minutes in 1991. In Seattle, the majority of cardiac arrest victims receive defibrillation within 5 to 7 minutes after the onset of cardiac arrest. No city has thus far been able to provide defibrillation for the majority of out-of-hospital cardiac arrest victims within five minutes of the onset of the event.

    Approaches are needed to identify and defibrillate cardiac arrest victims early in order to reduce mortality from OOH CA. A variety of approaches to enhancing a community's or a health-care system's ability to identify and treat OOH CA victims can be envisioned. Possible strategies include placing automated external defibrillators (AED) in public places, providing AEDs to families of high-risk patients, and utilizing telemedicine to identify OOH CA victims in their homes. There may be other possible appropriate strategies. Community organization, professional training, and public and patient education could be incorporated, as appropriate, to enable implementation of the selected strategy.

    Study Design

    This announcement is intended to encourage creative intervention approaches to achieving early access to defibrillation for OOH CA; accordingly, the announcement avoids specifying any particular approach. Proposals should use intervention strategies that aim to enhance early access to defibrillation for OOH CA and should include survival, morbidity, and functional outcome measures (such as activities of daily living). It is critical that any strategy employed be generalizable to a large segment of the OOH CA population, i.e., have major implications for public health. The peer review group will determine whether the proposed strategy is meritorious. Only randomized clinical trials will be considered responsive to the announcement. If technology or devices are to be incorporated into the intervention strategy, the technology or device should already have been proven to be efficacious and safe, and the intervention to be tested should focus on the approach or strategy for implementing the technology/device.


ATTACHMENT B

EVALUATION FACTORS FOR AWARD WITH TECHNICAL EVALUATION CRITERIA AND OTHER INFORMATION

GENERAL

The technical proposal will receive paramount consideration in the selection of the Contractor(s) for this acquisition. All evaluation factors, other than cost or price, when combined are significantly more important than cost or price. However, cost/price may become a critical factor in source selection in the event that two or more offerors are determined to be essentially equal following the evaluation of all factors other than cost or price. In any event, the Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered.

The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the BAA. Proposals will not be evaluated against each other since they are not submitted in accordance with a common work statement. All technical proposals will undergo evaluation by a peer review group also known as the Special Emphasis Panel (SEP). The SEP may include both Government and non-Government evaluations. The Division of Extramural Affairs, NHLBI will be responsible for administering this review. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the BAA. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below.

This research project involves human subjects. NIH Policy requires that women and members of minority groups and their subpopulations must be included in the study population of research involving human subjects, unless a clear and compelling rationale and justification is provided with respect to the health of the subjects or the purpose of the research. Where inclusion of women and minority populations is not feasible, a detailed rationale and justification for exclusion of one or both groups from the study population must be submitted with the technical proposal. The Government will review the rationale to determine if it is appropriate with respect to the health of the subjects and/or the purpose of the research. If the rationale is not considered acceptable and the proposal is included in the competitive range, the offeror will be afforded the opportunity to further discuss and/or clarify his/her position during discussions or to include women and minorities in your Final Proposal Revision (FPR). If the exclusion position is still considered unacceptable by the Government after discussions, the proposal may not be considered further for award.

Past performance is not an evaluation criterion but it will be considered when determining contractor responsibility using the information required by the "Qualifications of the Offeror" portion of the "Standard RFP Instructions and Provisions" of the RFP References Directory.

TECHNICAL EVALUATION CRITERIA

30 points A. Significance

Does this proposal address an important potential intervention approach to the problem of Out of Hospital Cardiac Arrest? Is the approach proposed generalizeable and expected to have an impact on public health, public policy, and/or clinical practice?

40 points B. Technical Approach

Is the study design adequate and appropriate for the question(s) being asked? Are the eligibility criteria, target population, and outcomes well specified and appropriate to the study? Is the ability to recruit the study participants needed to achieve the required sample size well documented? Are appropriate measures selected and are they measured in a valid and reliable manner? Is the intervention well specified, safe, and appropriate to achieve the desired results? Is compliance monitored? Is an appropriate sample size, power, and statistical/analytic approach proposed? Are the data management and quality control procedures adequate to maintain the quality of the study?

30 points C. Personnel, Coordination, and Facilities

Are adequate personnel with appropriate experience and expertise proposed in relevant areas, including study design and measurement, intervention, clinical areas (including cardiovascular disease, cardiac arrest, emergency medical services, and neurology), quality of life, cost effectiveness, and statistical design and analysis? Are the institutional experience and facilities adequate, including prior experience in similarly complex studies and the availability and adequacy of proposed facilities and equipment? Are the administrative structure and coordination adequately developed and appropriate?

100 Total Possible Points


ATTACHMENT C

SPECIFIC BAA INSTRUCTIONS AND PROVISIONS

NOTICE TO OFFERORS: This section contains proposal instructions and information which are specifically related to this acquisition. The information provided below is only a portion of the instructions and notices required for the submission of a proposal. References to additional, more general, information and forms regarding proposal preparation are contained in Attachment D titled, "Applicable RFP References".

An index of the specific BAA instructions and provisions, which apply, follow:

  1. Proposal Intent Response Sheet (submit prior to proposal submission-by January 29, 1999)
  2. Packaging and Delivery of Proposal
  3. Government Notice for Handling Proposals
  4. Privacy Act System of Records
  5. SIC Code and Small Business Size Standard
  6. Number and Type of Award(s)
  7. Estimate of Effort
  8. Service of Protest
  9. Technical Proposal Table of Contents
  10. Safety and Health
  11. Other Provisions


  1. PROPOSAL INTENT RESPONSE SHEET

    BROAD AGENCY ANNOUNCEMENT. NHLBI-HC-99-06 TITLE OF BAA: "Early Access to Defibrillation for Victims of Out-of-Hospital Cardiac Arrest (OOH CA)"

    FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY January 29, 1999. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT WILL ASSIST US IN PLANNING FOR PROPOSAL EVALUATION.


    I INTEND TO SUBMIT A PROPOSAL
    COMPANY/INSTITUTION NAME:
    ADDRESS:
    PROJECT DIRECTOR'S NAME:

    TITLE:

    TELEPHONE NUMBER:

    NAMES OF COLLABORATING INSTITUTIONS AND INVESTIGATORS

    (include Subcontractors and Consultants):

    ------------------------------------------------------------
    ------------------------------------------------------------

    RETURN TO:

    Review Branch
    NIH, NHLBI
    6701 Rockledge Drive, MSC 7924
    Bethesda, MD, 20892-7924
    Attention: Dr. James Scheirer

    or FAX TO: Dr. James Scheirer at (301) 480-3541


  2. PACKAGING AND DELIVERY OF THE PROPOSAL

    Your proposal shall be organized as specified in the "Standard RFP Instructions and Provisions." Shipment and marking shall be as follows:

    EXTERNAL PACKAGE MARKING
    In addition to the address cited below, mark each package as follows:

    "BAA NO. NHLBI-HC-99-06
    "TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

    The number of copies required of each part of your proposal are:

    TECHNICAL PROPOSAL: ORIGINAL* AND Twenty-five (25) COPIES
    BUSINESS PROPOSAL: ORIGINAL* AND Six (6) COPIES

    DELIVER PROPOSAL TO:

    If hand delivered or delivery service:

    Review Branch
    Division of Extramural Affairs
    National Heart, Lung, and Blood Institute
    Rockledge Building, Room 7091
    6701 Rockledge Drive MSC 7924
    Bethesda, MD 20817-7924

    If using U.S. Postal Service:

    Review Branch, Division of Extramural Affairs
    National Institutes of Health
    National Heart, Lung, and Blood Institute
    6701 Rockledge Drive MSC 7924
    Bethesda, MD 20892-7924

    *THE ORIGINAL PROPOSAL MUST BE READILY ACCESSIBLE FOR DATE STAMPING.


  3. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

    An offeror shall place this notice on top of each copy of its technical proposal:

    "This proposal shall be used and disclosed for evaluation purposes only, and a copy of this Government notice shall be applied to any reproduction or abstract thereof. Any authorized restrictive notices which the submitter places on this proposal shall also be strictly complied with. Disclosure of this proposal outside the Government for evaluation purposes shall be made only to the extent authorized by, and in accordance with, the procedures in HHSAR paragraph 315.608-72."


  4. PRIVACY ACT SYSTEM OF RECORDS

    This procurement action requires the Contractor to do one or more of the following: design, develop, or operate a system of records on individuals to accomplish an agency function in accordance with the Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 USC 552a) and applicable agency regulations. Violation of the Act may involve the imposition of criminal penalties.

    The Privacy Act System of Records Notice that applies to this RFP was published in the Federal Register dated April 7, 1997, Vol. 62, No. 66. This most recent notice will be incorporated into any contract resulting from this RFP. If you would like a copy, please contact the Contracting Officer identified in the cover letter to this RFP.


  5. SIC CODE AND SMALL BUSINESS SIZE STANDARD

    NOTE: The following information is to be used by the offeror in preparing its Representations and Certifications, specifically in completing the provisions entitled, SMALL BUSINESS PROGRAM REPRESENTATIONS, FAR 52.219-1:

    The standard industrial classification (SIC) code for this acquisition is 8731.

    The small business size standard is 500 employees.

    THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS. However, the FAR requires in every solicitation (except for foreign acquisitions) the inclusion of the SIC code and corresponding size standard which best describes the nature of the requirement in the solicitation.


  6. NUMBER AND TYPE OF AWARD(S)

    It is anticipated that one or more awards will be made from this Broad Agency Announcement and that award will be made in September, 1999.

    It is anticipated that the awards made from this solicitation will be a multiple-year cost reimbursement, completion type contract with a period of performance of 48 months, and that incremental funding will be used.


  7. ESTIMATE OF EFFORT

    To assist you in the preparation of your proposal, the Government considers funds to perform this work shall not exceed a total of $8,000,000 over a four year performance period for all award(s) made from this BAA. This estimate is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes.

    All staffing levels proposed should be accompanied by specific justifications as to the type and hours of work expected to be performed by all personnel. Offerors will be required to propose levels of commitment(s), whether compensated or donated effort, necessary to complete the work described in their proposals. It is expected that realistic levels of effort will be proposed such that an offeror's understanding of the work will be apparent.


  8. SERVICE OF PROTEST

    In accordance with FAR 52.233-2 SERVICE OF PROTEST (NOV 1988):

    1. Protests, as defined in Section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the General accounting Office (GAO) shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

      Ms. Lisa O'Neill
      Hand-Carried Address:
      National Institutes of Health
      National Heart, Lung, and Blood Institute
      Contracts Operations Branch
      II Rockledge Center, Room 6122
      6701 Rockledge Drive, MSC 7902
      Bethesda, MD 20817

      U.S. Postal Service:
      National Institutes of Health
      National Heart, Lung, and Blood Institute
      Contracts Operations Branch
      II Rockledge Center
      6701 Rockledge Drive, MSC 7902
      Bethesda, MD 20892-7902

    The copy of any protest shall be received in the office designated above within one day of filing a protest with GAO.


  9. TECHNICAL PROPOSAL TABLE OF CONTENTS

    Please number each page of text. Type density and size must be 10-12 points. If constant spacing is used, there should be no more than 15 cpi, whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch.

    The technical proposal should be organized as follows:

    1. TECHNICAL PROPOSAL COVER SHEET (Form is located in the Streamlined RFP References under "FORMS,FORMATS, ATTACHMENTS")--Page 1
    2. TECHNICAL PROPOSAL TABLE OF CONTENTS--Page 2
    3. ABSTRACT--Page 3
      State the proposal's broad, long-term objectives and specific aims. Briefly and concisely describe the research design and methods for achieving these goals. DO NOT EXCEED one page in providing the abstract. Identify the RFP Number, Institution and Principal Investigator on the abstract.
    4. TECHNICAL PLAN (approximately 25 PAGES)
      Refer to Technical Proposal Instructions located in the Standard RFP Instructions and Provisions under Streamlined RFP References or more detail.
      1. WORK STATEMENT
        1. Objectives--Page #
        2. Approach--Page #
        3. Methods--Page #
        4. Schedule--Page #
      2. PERSONNEL
        1. List of all Personnel in the project including Subcontractors, Consultants/Collaborators, by name, title, department and organization--Page #
          PROVIDE NARRATIVE FOR:
        2. Principal Investigator/Project Director--Page #
        3. Other Investigators--Page #
        4. Additional Personnel--Page #
          [NOTE: For personnel, include a two-page biosketch under APPENDICES below.]
      3. FACILITIES, EQUIPMENT AND OTHER RESOURCES--Page #
        List/describe all facilities, equipment and other resources available for this project.
      4. OTHER CONSIDERATIONS--Page #
        (Use specifically titled subparagraphs, as applicable.)

    5. OTHER SUPPORT--Page #
      Complete the Form "Summary of Current and Proposed Activities." All key personnel must be listed on this form. The form is located in the Streamlined RFP References under "FORMS, FORMATS, & ATTACHMENTS."

    6. TECHNICAL PROPOSAL COST INFORMATION--Page #
      (Form located in the Streamlined RFP References under "FORMS, FORMATS, & ATTACHMENTS.")

    7. LITERATURE CITED--Page #

    8. APPENDICES--Page #
      List each Appendix and identify the number of pages for each one. Appendices must be clear and legible, and easily located. Include biosketches here.


  10. SAFETY AND HEALTH DEVIATION PHS 352.223-70 (AUGUST 1997)

    1. To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State and local laws and regulations applicable to the work being performed under this contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration and other agencies at the Federal, State and local levels (Federal, State and local regulatory/enforcement agencies).

    2. Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer, in conjunction with the project or other appropriate officer, determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, an equitable adjustment will be made in accordance with applicable "Changes" Clause set forth in this contract.

    3. The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contract al all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

    4. If the Contractor fails or refuses to comply promptly with the Federal, State or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action (s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor.

    5. The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or operations.

      Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor.


  11. OTHER PROVISIONS

    NHLBI PUBLIC USE DATA PROVISIONS

    All study data will be deliverable to the U.S. Government, except personal identifiers. Public use data will be released under this BAA. After publication of the primary clinical trial results, the investigators shall prepare the data and deliver them to the NHLBI in a format suitable for use by the public. Such release is expected to occur no later than three years after the primary publication. The contractor shall provide the data to the NHLBI within two years of the primary publication so that the NHLBI can check the data before release. This will allow for the NHLBI review, discussion of the data, and opportunity for any changes needed in content or presentation prior to release. If the contract expiration date does not allow the contractor to comply with the above time frame, the data shall be prepared and delivered at least 30 days prior to the contract expiration date.

    The public use dataset will include the baseline visit, interim visit(s), and outcome data, including laboratory measurements. Inclusion of raw data that has been processed into summary information shall be discussed with the Project Officer prior to submission. Data prepared for release shall not contain personal identifiers. The contractor shall coordinate preparation of the data with the NHLBI to assure confidentiality. The data shall be submitted on CD-ROM, or other mutually agreed upon data medium that includes complete electronic documentation and data.

    The contractor shall produce clear documentation for the public use data. The documentation must allow for use by investigators not familiar with the dataset. The documentation must be written in WordPerfect or ASCII format, and must be included as a dataset in the storage medium. The study investigators will be expected to answer questions regarding dataset characteristics, format, and content. Documentation is expected to the of the highest quality so that such questions will be minimized. Ancillary study data (not funded under this contract) are not required to be included in the public use dataset, though the data may be included if agreed upon by the ancillary study investigator.

    Data will not be prepared for public use if the investigators and NHLBI believe that they are unreliable or invalid. These exceptions must be justified in writing to the NHLBI and will be reviewed and if the NHLBI concurs, will be approved in writing by the Director of the Division that sponsored the trial.

    Data to be presented in scientific publications and reports will be analyzed under the general direction of the Steering Committee and NHLBI Project Officer. Publications resulting from analyses of study data may be copyrighted by journal or book publishers.

    The contractee will transmit regular updates of the edited data to NHLBI as needed. Raw data will be made available to NHLBI whenever difficulties arise or upon request. All data collected will be used only for group analyses, and no information on individually identifiable participants will be sent to NHLBI or disseminated or used in publications or presentations.

    HUMAN MATERIALS (It is anticipated that this clause will appear in the contract.)

    It is understood that the acquisition and supply of all human specimen material (including fetal material) used under this contract will be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States and that no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

    PUBLICATION AND PUBLICITY (It is anticipated that this article will appear in the contract.)

    The contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

    "This project has been funded in whole or in part with Federal funds from the National Heart, Lung and Blood Institute, National Institutes of Health, under Contract No. "TBD"."

    The results from this study are anticipated to be disseminated primarily as original research papers in peer-reviewed scientific journals and as presentations at scientific meetings. The results will also be used to develop recommendations to enhance a community's or a health-care system's ability to identify and treat out-of-hospital cardiac arrest (OOH CA) victims.

    HHSAR 352.270-6 PUBLICATION AND PUBLICITY (JULY 1991) (It is anticipated that this clause will appear in the contract.)

    Unless otherwise specified in this contract, the Contractor is encouraged to publish, and make available through accepted channels, the results of its work under this contract. A copy of each article submitted by the Contractor for publication shall be promptly sent to the Project Officer. The Contractor shall also inform the Project Officer when the article or other publication is published, and furnish a copy of it as finally published.

    PHASING

    The first year of the project will focus on protocol development, pilot testing, and OMB clearance. The final protocol will be approved by the Steering Committee, reviewed by the NHLBI-appointed Data and Safety Monitoring Board (DSMB), and reviewed and approved by NHLBI staff before proceeding to the recruitment and examination phases of the project. In addition, the DSMB will meet at least once a year to review study progress and to provide recommendations on the direction of the study.

    GENERAL MONITORING PROCEDURES

    There will be a separate Steering Committee for each study funded under this announcement. The Steering Committee(s) will be composed of the study Principal Investigators, the NHLBI Project Officer, and other investigators as appropriate. The Steering Committee(s) will have the primary responsibility for planning and facilitating the conduct of the study and responding to issues raised by the Data and Safety Monitoring Board (DSMB). The Chair of the Steering Committee(s) will be appointed by the NHLBI. Progress will be reviewed by the Project Office, using progress reports, Steering Committee meetings, conference calls, and post-award site visits as stated in the statements of work and/or as necessary.

    Within contractual constraints and subject to NHLBI approvals, the Steering Committee(s) will provide general scientific direction for the study(ies) funded under this announcement. This responsibility includes protocol development, pilot study design and evaluation, monitoring and maintaining quality control, and analysis and publication of study data. Contractor progress will also be evaluated by recruitment reports, site visits, periodic progress reports, and direct NHLBI access to the main database. NHLBI approval for project continuation will be required after protocol development is complete.

    It is required that a Data and Safety Monitoring Board (DSMB) be established to monitor data and oversee patient safety in clinical trials. The DSMB, which will be appointed by the Director of NHLBI, is an operational component of NHLBI trials. A separate DSMB will be appointed for each study funded under this BAA. The DSMB will review the protocol prior to implementation. The protocol will define the study background, design, measurement, intervention, outcomes, quality control procedures, safety monitoring, analysis approach, and rules regarding access to data, type of data entry system, and publications. Progression from protocol development to participant enrollment is dependent upon the favorable recommendation of the DSMB and approval of NHLBI. The DSMB will review progress at least annually and report to the NHLBI. Its charge is to monitor baseline, adverse effects, and response variable data, and to evaluate contractor performance. It has the responsibility to recommend whether the study should continue, whether the protocol should be modified, or whether there should be early termination. Its ethical responsibilities to the participants, as well as to the integrity of the study, are of paramount importance to the NHLBI. The DSMB will provide reports to the Institute through an Executive Secretary, which will be the NHLBI Project Officer. The Chairperson of the Steering Committee of the study, the NHLBI Project Officer, and others as deemed necessary will attend meetings of the DSMB.

    OMB CLEARANCE

    Clearance of all forms used for any proposed participant recruitment, interim contact, and clinic examinations and scans that represent a burden of time to the participant must be cleared by the Office of Management and Budget (OMB) prior to use in the study, unless the study is determined to be appropriate for a clinical exemption.


ATTACHMENT D

APPLICABLE RFP REFERENCES

This section identifies the items located in the Streamlined RFP References that are applicable to this BAA

  1. The entire file titled "STANDARD RFP INSTRUCTIONS AND PROVISIONS" is applicable to this RFP, except as modified by the inclusion of items from the "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS"

  2. The following items are applicable from the file titled "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS":

  3. The following items are applicable to this specific RFP and are located in the file titled "FORMS, FORMATS, AND ATTACHMENTS", under Streamlined RFP References:

    SUBMIT WITH TECHNICAL PROPOSAL (with original and every copy of technical proposal)

    1. Technical Proposal Cover Sheet
    2. Summary of Current and Proposed Activities
    3. Technical Proposal Cost Information

    SUBMIT WITH BUSINESS PROPOSAL:

    1. A Contract Pricing Cover Sheet with every copy of business proposal.
    2. Proposal Summary and Data record, NIH-2043, with every copy of business proposal.
    3. Disclosure of Lobbying Activities, OMB SF-LLL, only one completed and signed original.
    4. Representations and Certifications, only one completed and signed original.

    OTHER - TO BE SUBMITTED LATER:

    1. Certificate of Current Cost or Pricing Data, NIH-1397, to be submitted with Final Proposal Revision, if required by the Contracting Officer.
    2. Small Business Subcontracting Plan, to be submitted as directed by the Contracting Officer.

    ANTICIPATED TO BE INCLUDED AS CONTRACT ATTACHMENTS:

    1. Invoice/Financing Requests Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1
    2. NIH 2706, Financial Report of Individual Project/Contract, the form with instructions
    3. Procurement of Certain Equipment, NIH(RC)-7
    4. Protection of Human Subjects Assurance/Identification/Certification/Declaration, OF 310

    The "SAMPLE CONTRACT FORMAT-GENERAL" under the Streamlined RFP References is applicable to this RFP. Selected clauses applicable to this acquisition will be included in the contract.


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